Chapter 2: The Food and Drug Administration
The Food and Drug Administration is charged by the federal government with responsibility to oversee the purity of most of the nation’s food and cosmetic products and the purity and effectiveness of the whole range of therapeutic agents sold in the United States. Its 2003 fiscal year budget is somewhat more than $1.7 billion but the agency’s potential effect on the country’s economy and welfare is far greater than might be assumed from this figure. Products accounting for no less than 25 cents of every dollar spent by American consumers are under the jurisdiction of the FDA, approximately $1 trillion annually, including all foodstuffs excepting meat and poultry and all human and animal drugs and therapeutic devices. The FDA’s mandate is immense inasmuch as it is empowered to determine which drugs are available to American consumers; it thus ultimately has the power of life and death over hundreds of thousands of people suffering from fatal illnesses. We must all, at one point or another, rely on the FDA’s permission to obtain and ingest what might prove a live-saving medication prescribed by our physician without which we might well die. Indeed, there can be no doubt that over the years the delays involved in FDA approval of therapeutic agents that have been shown to be life-saving have cost the lives of hundreds of thousands of Americans.1 Prior to the twentieth century, the federal government was involved in overseeing the nation’s food and drug supply in only the most marginal way. In...
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